Metastatic Hormone Sensitive Prostate Cancer Therapy Study
To provide Apalutamide plus androgen deprivation therapy treatment for patients with metastatic hormone sensitive prostate cancer and to collect additional data on treatment safety
In order to participate you must meet the following criteria:
- Have metastatic disease documented by ≥1 bone lesion(s) on Technetium-99m (99mTc) bone scan. Subjects with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI).
- Have started androgen deprivation therapy (ie, medical or surgical castration) ≥14 days prior to randomization. Subjects who start a GnRH agonist ≤28 days prior to randomization will be required to take a first-generation anti-androgen for ≥14 days prior to randomization. The anti-androgen must be discontinued prior to randomization.
- Have a maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization.
- Have had ≤6 months of ADT prior to randomization.
Have received docetaxel treatment and meet the following criteria:
- Have received a maximum of 6 cycles of docetaxel therapy for mHSPC.
- Have received the last dose of docetaxel ≤2 months prior to randomization.
- Have maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization.
You will be excluded from the study if any of the following criteria apply to you:
- Have lymph nodes as only sites of metastases.
- Have had prior treatment with other next generation anti-androgens (eg, enzalutamide), CYP17 inhibitors (eg, abiraterone acetate), immunotherapy (eg, sipuleucel-T), radiopharmaceutical agents or other treatments for prostate cancer.
This is a partial list of inclusion and exclusion criteria.